This server provides FDA and NHTSA regulatory-risk intelligence for AI agents, offering 14 tools to assess medical device risk, compliance, evidence, postmarket safety, reimbursement, and vehicle safety history.
Device Risk Lookup: Assess FDA compliance risk for a device category by product code, including recalls, MAUDE adverse-event trends, warning letters, and a composite risk score.
Firm Compliance History: Build a timeline of FDA public records for a firm, including recalls, warning letters, and Form 483 citations.
Watchlist Diff: Monitor machine-generated changes in FDA public records for specified product codes since a date.
Device Evidence Lookup: Retrieve structured premarket evidence for a device by 510(k) or De Novo number, including validation study design, sample sizes, endpoints, and performance metrics with verbatim source quotes.
Evidence Search: Search AI/ML device clearances by product code, panel, applicant, clinical data presence, sensitivity metrics, or PCCP.
Predicate Chain: Trace predicate ancestry of a 510(k) device, showing each predicate's age at clearance.
Evidence Cohort Stats: Get reporting-rate statistics across the AI/ML device corpus, optionally filtered by advisory panel.
Device Postmarket Lookup: Get post-clearance intelligence for a device, including recalls, MAUDE trends, warning letters, 483 matches, and drift signals.
Postmarket Search: Find devices by postmarket criteria such as drift signals, recalls in 24 months, or rising MAUDE trend.
Cohort Postmarket Stats: Get postmarket presence rates across the AI/ML cohort (recalls, rising MAUDE trends, drift signals, warning-letter matches), optionally by panel.
Reimbursement Lookup: Trace reimbursement pathways for a device by K/DEN or CPT code, including NTAP, CPT categories, CMS rates, HCPCS, and LCDs.
Reimbursement Search: Find payment pathways by mechanism, CPT category, NTAP status, or applicant.
Reimbursement Stats: Get distribution of payment mechanisms and dollar ranges across the reimbursement corpus.
Vehicle Risk Lookup: Look up NHTSA safety history for a vehicle by make, model, and year, including recalls and complaint statistics.
The MCP server behind Constat — FDA & NHTSA regulatory-risk intelligence for AI agents, over the Model Context Protocol. Live public regulatory data — recalls, adverse events, warning letters, 510(k) premarket evidence, postmarket drift signals, reimbursement pathways, and vehicle safety. Decision support, not regulatory advice.
Endpoint: https://constat.dev/api/mcp (legacy https://radar.healthai.com/api/mcp still serves)
Transport: Streamable HTTP (JSON-RPC 2.0)
Auth: none for anonymous access (30 requests/min per client); an optional
X-API-Key header enables the separately assigned metered allowance.
Registry: com.healthai/radar (official MCP registry)
The evidence corpus and tool logic run hosted at the endpoint above. This repo
also ships server.mjs, a zero-dependency stdio bridge to that endpoint, so
stdio-only MCP clients can use the server like any local one:
node server.mjs # stdio MCP server, bridges to constat.dev/api/mcp// e.g. in an MCP client config
{ "mcpServers": { "constat": { "command": "node", "args": ["/path/to/server.mjs"] } } }docker build -t constat-mcp . && docker run -i constat-mcp # same, containerizedTool | What it does |
| FDA compliance risk for a device category by 3-letter product code — recalls, MAUDE trend, warning-letter matches, composite score |
| Source-bounded FDA public-record timeline for a device firm — recalls, warning letters, 483s, clearances |
| Machine-detected FDA public-record changes for monitored product codes since a given date |
| Parsed 510(k) premarket evidence for an AI/ML device, each field with a verbatim source quote + page |
| Find AI/ML clearances by product code, panel, applicant, clinical data, sensitivity metric, or PCCP |
| Trace a device's predicate ancestry with each predicate's age at clearance |
| Reporting-rate stats across the parsed AI/ML corpus — presence figures with denominators |
| Post-clearance intelligence for one device — recalls, MAUDE trend, letter/483 matches, drift signals |
| Find devices by postmarket criteria — drift signals, recalls in 24mo, rising MAUDE trend |
| Postmarket presence rates across the AI/ML cohort, each with its denominator |
| Clearance-to-payment pathway by K/DEN or CPT code — NTAP, Cat I/III, CMS rates, HCPCS, LCDs |
| Find payment pathways by mechanism, CPT category, NTAP status, applicant |
| Mechanism distribution across the reimbursement corpus with dollar ranges |
| NHTSA safety history by make/model/year — recall campaigns and complaint stats |
Related MCP server: fedramp-docs-mcp
curl -s https://constat.dev/api/mcp \
-H 'content-type: application/json' \
-H 'accept: application/json, text/event-stream' \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
"params":{"name":"device_risk_lookup","arguments":{"product_code":"FRN"}}}'List tools with {"method":"tools/list"}. Note the Accept header must include
text/event-stream (streamable-HTTP requirement).
Each of the 14 tools declares an output schema. Tool calls return structured
content with an explicit ok, not_found, invalid_request, or unavailable
status while preserving a text result for older clients.
See the integration guide, architecture and trust boundaries, privacy notice, and support page.
Clarity MCP — condition-aware ingredient, product & supplement safety (verdict + evidence tier + citation).
MCP Queen — the graded MCP registry that independently probes and grades this server.
Built by Health AI, the team behind Constat. Informational only; verify against primary FDA/NHTSA sources.
MIT — see LICENSE.
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Agent-native MCP server over the public saagarpatel.dev corpus. Read-only, stateless.
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curl -X GET 'https://glama.ai/api/mcp/v1/servers/thehealthai/fda-risk-radar-mcp'
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